Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-24 @ 1:17 PM
NCT ID:
NCT01166295
Eligibility Criteria:
Inclusion Criteria:
* Subject is between 40 and 85 years old.
* Physician documentation of history of postherpetic neuralgia must be provided; pain persisting more than 3 months/90 days after a patient's vesicular rash (shingles) has healed.
* Subject is able to speak, read and write in English and comply with all study procedures;
* Subject is willing to voluntarily sign and date an Informed Consent Form, approved by an IRB, prior to the conduct of any study-specific procedures;
* Subject must be willing to abstain from PRN (as needed) pain medicine for 12 hours prior to the study but may continue their standing doses of pain medicine.
Exclusion Criteria:
* Subject is pregnant and/or breast-feeding.
* Subjects with additional sources of chronic pain will not be allowed if the severity of pain in additional locations is severe enough to compromise assessment of PHN pain. This will be left to the Investigator's discretion.
* Subject has a medical condition, other than PHN, that is not well-controlled with treatment; or the subject has any clinically significant condition that would, in the opinion of the investigator, preclude study participation, interfere with the assessment of pain, or pose unacceptable risk to the participant.
* Subject has been enrolled in another study within 30 days.
* Subject has a known contact allergy to surgical skin markers.
* In the judgment of the investigator, the subject has a psychiatric or psychological disorder that would interfere with the completion of the study, confound the study results, or pose patient risk.
* Subject has neuropathy or nerve fiber disease other than PHN (e.g., diabetic peripheral neuropathy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT01166295
Study Brief:
Protocol Section:
NCT01166295